Long-term Evaluation of Intrarectal Botulinum Toxin Injection Sessions for Treating Urge and Mixed Fecal Incontinence: Results from a Monocentric Historical Cohort.

BACKGROUND

There is a lack of long-term data on the outcomes of intrarectal botulinum toxin injections as a new option therapy for urge fecal incontinence, particularly following reinjection sessions, reasons for treatment dropout, and safety data.

OBJECTIVE

The objective of this study was to detail the outcomes of intrarectal botulinum toxin injections in our monocentric historical cohort with the longest known follow-up to date.

DESIGN

This retrospective study included patients who underwent at least one intrarectal injection session of botulinum toxin administered during sigmoidoscopy.

PATIENTS: We included patients who were being treated at our center for urge fecal incontinence with failure of first-line or second-line therapy.

MAIN OUTCOME MEASURES: Treatment success after the injection sessions required patient satisfaction, with none to moderate symptoms and the absence of additional treatments (excluding medication).

RESULTS

Seventy-nine patients were included (median age: 62.0 (51.0-69.0); 77/79 female gender) with a median follow-up of 37.0 (10.0 to 72.0) months. A total of 238 injection sessions were performed (median number of 1.0 (0.5-1.8) injection session by patient year of follow-up) with 76% efficacy after the first injection session. The median delay between reinjection sessions was 12.5 months (9.8 to 20.3). Twenty-nine patients experienced treatment failure (36.7%) during follow-up, mainly because symptoms did not improve significantly. A decrease from 11 (9.0 to 15.0) to 9.0 (5.0 to 12.0) was observed for the median Cleveland score. Eighty-eight nonserious adverse events, mainly constipation, were observed in 47 patients (59.5%).

LIMITATIONS: As the present study was monocentric, the number of patients included was limited, albeit the patient cohort was larger than in most other published series.

CONCLUSIONS

Intrarectal botulinum toxin injections for urge fecal incontinence seem to be efficacious in the long term. Further studies need to focus on injection methods and standardize follow-up and reinjection criteria. (See Video Abstract).